- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706678
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
July 26, 2022 updated by: Astellas Pharma China, Inc.
Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study
The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China
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Changchun, China
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Chengdu, China
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Guangzhou, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Shenyang, China
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Wuhan, China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years of age, male or female
- 1-5 years after kidney transplantation
- The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
- The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
- At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
- gingival hyperplasia and treatment requested by the patient
- polytrichia and interventional therapy requested by the patient
- post-transplantation hypertension
- post-transplantation hyperlipemia (total cholesterol>5.7 mmol/L (220 mg/dl))
- Serum creatinine<200 μmol/l ( 2.3 mg/dl)
- A promise is made to take contraceptive measures during the study (women at childbearing ages).
Exclusion Criteria:
- Patients having accepted transplantation of other organs apart from kidney transplantation
- Patients with 24-hour urine protein>2 g
- Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
- Patients with refractory infectious foci
- Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
- Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
- Patients allergic to tacrolimus or other basic medications
- Pregnant or lactating women
- Patients having participated in other clinical trials within the previous month
- Other patients who are considered by doctors unsuitable for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus sustained-release capsule group
Oral
|
Oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in creatinine level
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in creatinine level
Time Frame: Baseline and Weeks 1, 2, 4, 8 and 12
|
Baseline and Weeks 1, 2, 4, 8 and 12
|
|
Incidence of rejection reaction after drug use
Time Frame: Up to Week 24
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Up to Week 24
|
|
Plasma concentrations of tacrolimus
Time Frame: Weeks 1, 2, 4, 8, 12 and 24
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Weeks 1, 2, 4, 8, 12 and 24
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Change from baseline in blood pressure
Time Frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Diastolic pressure and systolic pressure
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Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Change from baseline in blood lipid
Time Frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride
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Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Change from baseline in liver function
Time Frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
|
Aspartate aminotransferase, alanine aminotransferase, bilirubin
|
Baseline and Weeks 1, 2, 4, 8, 12 and 24
|
Change from baseline in fasting blood glucose
Time Frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Baseline and Weeks 1, 2, 4, 8, 12 and 24
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Change from baseline in gingival hyperplasia
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Change from baseline in polytrichia
Time Frame: Baseline and Week 24
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Baseline and Week 24
|
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Safety assessed by Adverse Events
Time Frame: Up to 24 weeks
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Up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 8, 2016
First Submitted That Met QC Criteria
March 8, 2016
First Posted (Estimate)
March 11, 2016
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJ309CT-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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